Sumatriptan 50mg Tablets
Sumatriptan 50 mg Tablets Patient Information Leaflet
In this leaflet:
1. What these tablets do
2. Check before you take ...
3. How to take the tablets
4. Possible side effects
5. Storing your medicine
6. More about the medicine
7. More about migraine
Read this leaflet carefully before taking these tablets.
Remember this medicine is for you. Never give the tablets to someone else, because it may harm them, even if their symptoms seem to be the same as yours.
Keep this leaflet - you may need to read it again. It contains important information.
You must tell your doctor if your pharmacist has confirmed you have migraine and if you take Sumatriptan Tablets.
If you have any further questions or there is anything you do not understand, ask your doctor or pharmacist.
Throughout this leaflet, Sumatriptan 50 mg Tablets are referred to as Sumatriptan Tablets.
1. What these tablets do
Sumatriptan Tablets are used to treat migraine. These tablets contain sumatriptan, which belongs to a group of medicines called triptans (5-HT, receptor agonists). Migraine symptoms may be caused by the temporary swelling of blood vessels in the head due to a temporary imbalance in the body’s natural chemicals.
The tablets are believed to work on this imbalance and reduce the swelling of these blood vessels. The tablets help to take away the headache and other symptoms of a migraine attack such as feeling sick (nausea) and sensitivity to light and sound. They start to relieve migraine headache about 30 minutes after you take them.
2. Check before you take .
Don’t take Sumatriptan Tablets:
• unless you suffer from migraines (a doctor or pharmacist needs to confirm this)
• if you are trying to prevent a migraine attack - only take it when your migraine headache begins
• until you are sure this is a migraine and not just a headache
• if you are under 18 or over 65
• if you have had an allergic reaction to sumatriptan, or any of the other ingredients in the tablets, or to sulphonamide antibiotics
• if you have heart problems including heart failure, a previous heart attack, angina (chest pain), or an irregular heartbeat
• if you have had a stroke or a mini-stroke (also called a transient ischaemic attack or TIA)
• if you have high blood pressure or are being treated for it
• if you have kidney or liver disease
• if you have epilepsy or are prone to seizures (fits)
• if you have circulation problems in your legs and have cramp-like pains in your legs when you walk, or if your doctor has told you that you suffer from peripheral vascular disease
• if your doctor diagnosed one of the rare forms of migraine (hemiplegic; basilar or opthalmoplegic migraine).
Don’t take Sumatriptan Tablets with these medicines:
■ antidepressants called monoamine oxidase inhibitors (MAOIs), for example, phenelzine, isocarboxazid, tranylcypromine. If you take these or if you have taken them in the last two weeks, don’t take Sumatriptan Tablets.
(If you are taking antidepressants and are not sure what they are, talk to your doctor or pharmacist.)
■ certain other migraine treatments. Do not take Sumatriptan Tablets if you have taken a medicine containing a triptan (including other sumatriptan-containing products, zolmitriptan, rizatriptan, naratriptan) or medicines containing ergotamine or methysergide within the last 24 hours.
After taking Sumatriptan Tablets you should wait at least 24 hours before taking a medicine containing a triptan (including other sumatriptan-containing products, zolmitriptan, rizatriptan, naratriptan) or at least 6 hours before taking a medicine containing ergotamine or methysergide.
Take special care with Sumatriptan Tablets:
Your pharmacist will have checked the points listed below to make sure this medicine is right for you.
■ if you have three or more risk factors:
- you are a man over 40, or a woman who has had the menopause
- you are very overweight
- you are a regular smoker (more than 10 cigarettes a day)
- you have diabetes
- you have high cholesterol
- you have a close relative who developed early heart disease - either your father or brother developed heart disease before the age of 55, or your mother or sister developed heart disease before the age of 65.
If three or more of the points above apply to you, you may be at higher risk of heart disease
- see your doctor without taking Sumatriptan Tablets. If you are not sure, your pharmacist or doctor can help.
■ if your headaches usually last longer than 24 hours, or become more frequent
■ if you generally have four or more migraine attacks each month
■ if you do not recover completely in between your migraine attacks
■ if you are over 50 and this is your first headache of this type
■ if your migraine attacks get worse or become more frequent, or your symptoms change
■ if your migraine includes symptoms such as
- weakness on one side of your body
- clumsy and un-co-ordinated movements
- reduced level of consciousness
- a recent rash with a headache
- double vision
- tinnitus (ringing in the ears)
- seizure (fit)-like movements
If any of the points in this list apply to you, and you haven’t already talked to a pharmacist or doctor about these, get their advice before taking Sumatriptan Tablets.
If you are taking other medicines:
■ Some antidepressants and some migraine medicines mean you can’t take Sumatriptan Tablets.
See above under “Don’t take Sumatriptan Tablets with these medicines.”
■ Antidepressants called SSRIs or SNRIs (Selective Serotonin Reuptake Inhibitors or Serotonin Noradrenaline Reuptake Inhibitors) - for example citalopram, fluoxetine, paroxetine, fluvoxamine, sertraline, duloxetine and venlafaxine. Using Sumatriptan Tablets with this group of medicines can make some side effects more likely. If you experience uncontrolled twitching or jerking of the muscles, sweating, and/or changes in mental status such as confusion or agitation after using Sumatriptan Tablets, tell a doctor straight away. If you are not sure if you are taking an SSRI or SNRI, check with your doctor or pharmacist.
■ Tricyclic antidepressants - for example doxepin and amitriptyline. Using Sumatriptan Tablets with this group of medicines may make some side effects more likely. If you are worried, talk to your pharmacist or doctor.
■ Certain types of contraceptive pill - women with migraine who are taking a combined oral contraceptive pill have a higher risk of stroke. If you are taking these contraceptive pills and you only recently started to have migraines (in the last 3 months), or your migraine symptoms have got worse, or you have migraine with aura (attacks that start with disturbed vision or a change in sensation such as ‘pins and needles’), talk to your doctor.
■ St John’s wort (a herbal remedy - Hypericum perforatum) - using St. John’s Wort with Sumatriptan Tablets may increase the likelihood of you suffering side effects. If you are worried, talk to your pharmacist or doctor.
Pregnancy and breast-feeding
If you are pregnant or could be pregnant, or you are breast-feeding, do not take Sumatriptan Tablets unless you’ve agreed it with your doctor.
Driving and using machines
Either the symptoms of migraine or your medicine may make you drowsy. If you are affected, do not drive or operate machinery.
Sumatriptan Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Sumatriptan Tablets.
3. How to take the tablets
Adults aged 18 to 65
■ Take one tablet as soon as possible at the first signs of a migraine headache.
■ If your symptoms start to come back, you can take a second tablet after 2 hours. You must leave at least 2 hours after the first tablet.
Swallow each tablet whole with water.
Don’t take more than two tablets in 24 hours.
Don’t take more than two tablets for the same attack.
If the first tablet does not provide any relief:
Don’t take a second tablet.
If you use Sumatriptan Tablets too often, it may make your headaches worse. If this happens you should consult your doctor or pharmacist, who may tell you to stop taking Sumatriptan Tablets.
You should wait at least 24 hours before taking a medicine containing a triptan (including other sumatriptan-containing products, zolmitriptan, rizatriptan, naratriptan) or at least 6 hours before taking a medicine containing ergotamine or methysergide.
Talk to your doctor before you take any more Sumatriptan Tablets. Getting no relief at all from Sumatriptan Tablets may mean that you do not have migraine.
Sumatriptan Tablets are only to relieve migraine symptoms.
Don’t take it to try to prevent an attack. Don’t take it until you are sure it’s a migraine and not just a headache.
Children under 18 and adults over 65
Do not take this medicine if you are under 18 or over 65 and have migraine symptoms. Talk to your doctor.
What should I do if I take too many tablets?
Taking too much could make you ill. Keep to the dose and follow the instructions.
If you take too many tablets, tell a doctor straight away. Take the box and this leaflet with you.
4. Possible side effects
Sumatriptan Tablets can cause side effects, but not everybody gets them.
Allergic reactions: get doctor’s help straight away
(affect less than 1 in 10,000 people)
Some people may be allergic to these tablets.
Signs of allergy include rash; wheezing; breathlessness; swollen eyelids, face or lips; complete collapse.
If you get any of these symptoms soon after taking Sumatriptan Tablets, don’t take any more.
Tell a doctor straight away, Take the packaging and this leaflet with you.
Very rare side effects: tell doctor as soon as possible
(affect less than 1 in 10,000 people)
■ Pain in the lower left side of the stomach and bloody diarrhoea.
■ Pale, blue-tinged skin and/or pain in your fingers, toes, ears, nose or jaw in response to cold or stress (Raynaud’s phenomenon).
■ Seizures/fits.
Common side effects: tell doctor if long or severe
(affect less than 1 in 10 people)
These effects usually develop within 30 minutes of treatment, and are not usually troublesome. They may be intense, but they do not last long.
■ Heaviness, pressure, tightness or pain in the chest, throat or other parts of the body, or feelings of tingling or warmth.
■ Unusual sensations including reduced sensation or numbness and feeling hot/cold.
If these effects continue for more than two hours, or are particularly severe (especially the chest pain), tell your doctor straight away. In a very small number of people, these symptoms can be caused by a heart attack.
Other side effects: speak to a pharmacist if you are worried
Very rare (affect less than 1 in 10,000 people)
■ Visual disturbances - although this is often part of the migraine attack itself.
■ Uncontrolled movements, shaking or tremors.
■ Heart beat may go faster, slower or change rhythm.
■ Angina or heart attack.
■ Liver function changes. If you have a blood test to check your liver function tell your doctor or nurse that you are taking Sumatriptan Tablets.
■
Common (affect less than 1 in 10 people)
■ Feeling sick (nauseous) or being sick (vomiting) - although this is often part of the migraine attack itself.
■ Tiredness or drowsiness.
■ Dizziness, feeling weak, or getting hot flushes.
■ Feeling faint (blood pressure may go up or down).
■ Shortness of breath.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. Storing your medicine
This medicinal product does not require any special storage conditions. Do not use the tablets after the ‘use by end of date shown on the carton.
Remember: Keep all medicines out of the sight and reach of children.
6. More about the medicine
Active ingredient Each tablet contains 50 mg of sumatriptan (as the succinate).
Other ingredients of the tablet are Lactose monohydrate, croscarmellose sodium, lactose anhydrous microcrystalline cellulose, magnesium stearate. Tablet coat: Lactose monohydrate, mannitol, titanium dioxide E171, talc, triacetin.
Sumatriptan Tablets pack contain two 50 mg tablets. Each film-coated tablet is white, oval, biconvex, 6.5x12.7 mm coated tablets with score on both sides and side score, embossed with SN on one side and “50” on the other side.
Marketing Authorisation Holder
Actavis Group PTC ehf Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
Manufacturer
Actavis hf Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland.
Or
Specifar S.A,1, 28 Octovriou str,123 51 Ag. Varvara, Athens, Greece
7. More about migraine
Migraine can be hard to live with, disrupting normal life for days at a time. Sometimes attacks happen for no apparent reason, but some people find that their migraines are triggered by something. Triggers might include:
■ food and drink: chocolate; cheese; red wine; citrus fruits; irregular meals; coffee, tea or cutting down on caffeine
■ rest and relaxation: too much or too little sleep; stress, or relaxation after a period of stress; too much or too little exercise; smoking
■ changes in hormones: e.g. monthly periods; the Pill; the menopause
■ atmosphere: flashing lights; noise; changes in weather; strong smells
It may help to keep a migraine diary. Note down when and where each migraine attack started, what you were doing, and what you had eaten that day. You may see a pattern, and it may be possible to avoid one or more things that is triggering your attacks. Cutting out triggers does not always prevent a migraine -most migraines are not caused by a single, identifiable trigger but by a combination of factors.
For further information about your migraine you can contact:
Migraine Action Association Phone: 0870 0505898.
Unit 6 Oakley Hay Lodge Business Park, Great Folds Road, Great Oakley, Northants NN18 9AS.
The Migraine Trust Phone: 020 7436 1336 55-56 Russell Square, London WC1B 4HP
This leaflet was last revised in: April 2016
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